Regional AnesthesiaNCT05015985
MUSIC-CARE and Locoregional Anesthesia for Orthopedic Surgery
A study testing Music-Care in people with Regional Anesthesia and Music, run by American Hospital of Paris at 1 site in France.
Trial summary
Anxiety, fright, stress and pain have always been sources of emotional distress for patients undergoing invasive procedures in clinical settings. Experts have long used traditional methods such as analgesics and anxiolytics to address these issues. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Regional Anesthesia, Music, Forearm; Injury, Superficial, Multiple (With Elbow)
- What is being tested?
- Music-Care
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 10 Mar 2023to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- scheduled forearm orthopedic surgery
- locoregional anesthesia
Who cannot join
- age below 18 yrs or up to 80 yrs
- emergency
- surgery duration up to 90 minutes
- patient refusing locoregional anesthesia
- local contreindication to locoregional anesthesia
- patients who do not like music for cultural reason,
- patients having serious psychiatric disorder or cognitive disease
- patients with not paired deafness or paired one with devices that were incompatible with wearing a headset.
Trial locations and contacts
1 site in 1 country.
France1 site
American Hospital of Paris
Neuilly-sur-Seine, 92200
Gilles BOCCARA, MD, PhD, +33 1 46 41 26 91, gilles.boccara@ahparis.org
Thierry GUENOUN, MD, +33 1 46 41 29 68, thierry.guenoun@ahparis.org
About this study
Official title: Benefits of a Music-based Self-relaxing Program Application (MUSIC-CARE) Combined to Locoregional Anesthesia for Forearm Orthopedic Surgery : A Randomized Trial
Anxiety, fright, stress and pain have always been sources of emotional distress for patients undergoing invasive procedures in clinical settings. Experts have long used traditional methods such as analgesics and anxiolytics to address these issues. But, backed by a movement aiming at reducing the use of pharmacological products, alternative interventions, including music therapy, have gained some steam in recent years. These interventions may have the ability to reduce pain and anxiety while increasing relaxation, coping skills and the overall experience of the procedure. For orthopedic surgery, anesthetics could propose general anesthesia or locoregional anesthesia. The upper limb orthopedic surgery is often performed under locoregional anesthesia and in the ambulatory procedure. However, with the known exacerbating effects of stress and anxiety on pain, the affective experience of the patient can be negatively influenced. In order to mitigate these problems, various types of sedatives and anxiolytics and even low-dose propofol can be used.
The Montpellier Regional University Hospital, along with the Music Care Company developed a software so as to standardize this technique around these recommendations. This model demonstrated its efficacy in both acute and chronic pain settings. Indeed, a single music therapy session was found to be effective for decreasing anxiety and promoting relaxation, as indicated by decreases in heart rate, blood pressure, BIS and respiratory rate over the intervention period in intubated patients during weaning phase. Also, a patient-controlled music intervention administered by Music Care has shown to alleviate negative psychological (e.g., depression) and physiological (e.g., pain and discomfort) outcomes and, very importantly, to reduce the consumption of medication in patients with chronic pain due to lumbar pain, fibromyalgia, inflammatory or neurological diseases.
Given the recent availability of a standardized and proven delivery method of music therapy (i.e. MUSIC-CARE), the principal aim of this randomized clinical trial is to assess the effect of this music therapy program delivered by application compared to usual playlist music on drug consumptions and physiological parameters, pain, anxiety levels in patients undergoing forearm orthopedic surgery under locoregional anesthesia.
Read the detailed description
This is a randomized controlled clinical study on patients who were followed during their forearm orthopedic surgery. The research has been submitted and approved by the Institutional review Board (IRB) at the American Hospital of Paris. Before their inclusion in the study, after to give their consentment, patients were verbally given details about the methods and techniques of the music session.
Patients scheduled to undergo forearm orthopedic surgery (SR) under regional anesthesia are recruited in this study. They are assigned to one of 2 groups in a randomized manner. Excluding criteria are age less 18 years or up 80 years, patients who do not like music for cultural reason, having serious psychiatric disorder, or with not paired deafness or paired one with devices that were incompatible with wearing a headset. After randomization, patients are placed in the control group, using a music support from playlist, or assigned to the MUSICARE group.
In both group, after per os hydroxyzine premedication, each patient received a regional anesthesia using mepivacaine 2%, at least 20 minutes before skin incision under tourniquet. The regional anesthesia is performed using either an axillary plexus block or mild-arm trunk nerve block with electrical nerve stimulation and ultrasound nerve localization. The music support is started before to do the regional anesthesia and continued during all the orthopedic procedure. According to the anxiety level and patient request, an intravenous titration of midazolam was infused 1 mg per 1 mg to get a sedative score less or equal to 1. If this target is not met after 3 mg of midazolam, the anesthetist could infuse a low dose of propofol (20 mg).
During all the procedure, the anesthetist performing the regional anesthesia and the intravenous hypnotic administration, is blinded about the patient group and musicThe Music-Care app is a receptive music intervention, allowing the patient to freely adjust the length of and choose the preferred style between different sequences of instrumental music. All musical pieces were recorded in high-quality recording studios with professional musicians.
Music-Care utilizes the "U" technique, designed to gradually relax the listener. In the current study, music sequences during patients' sessions were based on the mount "U", and instrumental musical works were selected for a varying numbers styles (classical, jazz, world music, etc.) and adapted to the patient's style via patient request. The "U" technique is implemented using a musical sequence of 20 minutes that was divided into 5 different musical pieces at 3 to 4 minutes each. Initially, the objective is to represent the patient's state of tension by stimulating musical rhythm of 80-95 beats per minute (bpm). From there, the remaining 4 sub-pieces are presented in a blended fashion in an attempt for the patient to gradually fall into a relaxed state via a gradual reduction in musical tempo (40-80 bpm), orchestral size, frequencies, and volume (descending arm of the "U"). The music session then reaches a phase of maximum relaxation (downward phase of the "U") before a phase that gradually returns to baseline dynamics (ascending arm of the "U").
In the control group, a music program from an established playlist with various instrumental music is chosen by the patient and delivered by the same tablet.
program. The primary study end points were the consumptions in sedatives (midazolam and propofol), from 10 minutes prior to the procedure until its end. Secondary study end points were pain and anxiety scores as measured the Numeric Rating Scale (NRS) and the Amsterdam Preoperative Anxiety and Information Scale (APAIS), collected before and right after the end of the procedure in the recovery room. We also evaluated the physiological parameters, such as sedation score ( 0: awake; 1: unconsciousness but reactive to verbal stimulation; 2: unconsciousness but reactive to nociceptive stimulation; 3: areactive to stimulation) , heart rate, arterial blood pressure, oxygen saturation at different time points between T0 (10 minutes prior to the beginning of the procedure) and T45 (45 minutes after it). Satisfaction was also collected using a scale from 0 to 5, with a higher score for a high satisfaction, right after the end of the procedure in the recovery room.
- Being tested
- Music-Care, control group
- Keywords
- musicotherapy,, anxiety, pain, locoregional anesthesia, orthopedic surgery, Musicare
- Medical subject headings
- Wounds and Injuries, Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music-CareOther
music relaxation by a specific hardware and software program application (MUSIC-CARE)
control groupOther
music relaxation using a music playlist supply (control group)
| Study group | Role | What they receive |
|---|---|---|
| MUSIC-CARE Group | Active comparator | In the Music-Care group, a program of music therapy was administered through a hardware and software provided to the investigative team by the Music-Care Company. The standardized techniques include three sequences in which the relaxing, maintenance and simulating times differ.
Music-Care utilizes the "U" technique designed to gradually relax the listener. In the current study, music sequences during patients' sessions were based on the mount "U", and instrumental musical works were selected for a varying numbers styles (classical, jazz, world music, etc.) and adapted to the patient's style via patient request. Receives: Other: Music-Care |
| CONTROL group | Sham comparator | In the control group, a music program from an established playlist with various instrumental music is chosen by the patient and delivered by the same tablet. Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
sedative requirement
midazolam and/or propofol peroperative consumption in milligramme
Measured: during the intraoperative period
Secondary outcomes (4)
anxiety score change
Numeric Rating scale NRS of anxiety from 0 to 10
Measured: during the intraoperative period
pain score change
Numeric Rating Scale NRS of pain intensity from 0 to 10
Measured: during the intraoperative period
sedation score change
score of sedation from 0 (awake) to 3 (areactive to stimulation)
Measured: during the intraoperative period
satisfaction score
score of patient satisfaction from 0 to 5
Measured: in postoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start10 Mar 2023 (estimated)
- Primary completion15 Mar 2023 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Regional AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this study, the investigators compare a specific program of music therapy to an usual music support by playlist. The specific program MUSIC-CARE is administered through a hardware and software, consisting of a modern tablet. The Music-Care app is a receptive music intervention, allowing the patient to freely adjust the length of and choose the preferred style between different sequences of instrumental music. All musical pieces were recorded in high-quality recording studios with professional musicians. Music-Care utilizes the "U" technique designed to gradually relax the listener. Initially, the objective is to represent the patient's state of tension by stimulating musical rhythm of 80-95 beats per minute (bpm). Then, it gradually falls into a relaxed state via a gradual reduction in musical tempo (40-80 bpm), orchestral size, frequencies, and volume (descending arm of the "U").
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American Hospital of Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gilles BOCCARA, American Hospital of Paris
- Investigators
- Gilles BOCCARA, MD, PhD, Principal investigator, American Hospital of Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05015985
- Sponsor's protocol ID
- MUSICARE/ALR/ORTHO1
- Status last verified
- Mar 2023
- First submitted
- 24 Apr 2021
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hole J, Hirsch M, Ball E, Meads C. Music as an aid for postoperative recovery in adults: a systematic review and meta-analysis. Lancet. 2015 Oct 24;386(10004):1659-71. doi: 10.1016/S0140-6736(15)60169-6. Epub 2015 Aug 12.
PubMed 26277246Guetin S, Ginies P, Siou DK, Picot MC, Pommie C, Guldner E, Gosp AM, Ostyn K, Coudeyre E, Touchon J. The effects of music intervention in the management of chronic pain: a single-blind, randomized, controlled trial. Clin J Pain. 2012 May;28(4):329-37. doi: 10.1097/AJP.0b013e31822be973.
PubMed 22001666Graff V, Cai L, Badiola I, Elkassabany NM. Music versus midazolam during preoperative nerve block placements: a prospective randomized controlled study. Reg Anesth Pain Med. 2019 Jul 18:rapm-2018-100251. doi: 10.1136/rapm-2018-100251. Online ahead of print.
PubMed 31320504Fu VX, Oomens P, Sneiders D, van den Berg SAA, Feelders RA, Wijnhoven BPL, Jeekel J. The Effect of Perioperative Music on the Stress Response to Surgery: A Meta-analysis. J Surg Res. 2019 Dec;244:444-455. doi: 10.1016/j.jss.2019.06.052. Epub 2019 Jul 18.
PubMed 31326711Zengin S, Kabul S, Al B, Sarcan E, Dogan M, Yildirim C. Effects of music therapy on pain and anxiety in patients undergoing port catheter placement procedure. Complement Ther Med. 2013 Dec;21(6):689-96. doi: 10.1016/j.ctim.2013.08.017. Epub 2013 Sep 1.
PubMed 24280479
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of a Music-based Self-relaxing Program Application (MUSIC-CARE) Combined to Locoregional Anesthesia for Forearm Orthopedic Surgery : A Randomized Trial
- ClinicalTrials.gov ID
- NCT05015985
- Acronym / sponsor ID
- MUSICARE/ALR/ORTHO1
- Keywords
- musicotherapy,, anxiety, pain, locoregional anesthesia, orthopedic surgery, Musicare
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- American Hospital of ParisUniversity, hospital or other
- Study start
- 10 Mar 2023 (estimated)
- Primary completion
- 15 Mar 2023 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 23 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Anxiety, fright, stress and pain have always been sources of emotional distress for patients undergoing invasive procedures in clinical settings. Experts have long used traditional methods such as analgesics and anxiolytics to address these issues. But, backed by a movement aiming at reducing the use of pharmacological products, alternative interventions, including music therapy, have gained some steam in recent years. These interventions may have the ability to reduce pain and anxiety while increasing relaxation, coping skills and the overall experience of the procedure. For orthopedic surgery, anesthetics could propose general anesthesia or locoregional anesthesia. The upper limb orthopedic surgery is often performed under locoregional anesthesia and in the ambulatory procedure. However, with the known exacerbating effects of stress and anxiety on pain, the affective experience of the patient can be negatively influenced. In order to mitigate these problems, various types of sedatives and anxiolytics and even low-dose propofol can be used.
The Montpellier Regional University Hospital, along with the Music Care Company developed a software so as to standardize this technique around these recommendations. This model demonstrated its efficacy in both acute and chronic pain settings. Indeed, a single music therapy session was found to be effective for decreasing anxiety and promoting relaxation, as indicated by decreases in heart rate, blood pressure, BIS and respiratory rate over the intervention period in intubated patients during weaning phase. Also, a patient-controlled music intervention administered by Music Care has shown to alleviate negative psychological (e.g., depression) and physiological (e.g., pain and discomfort) outcomes and, very importantly, to reduce the consumption of medication in patients with chronic pain due to lumbar pain, fibromyalgia, inflammatory or neurological diseases.
Given the recent availability of a standardized and proven delivery method of music therapy (i.e. MUSIC-CARE), the principal aim of this randomized clinical trial is to assess the effect of this music therapy program delivered by application compared to usual playlist music on drug consumptions and physiological parameters, pain, anxiety levels in patients undergoing forearm orthopedic surgery under locoregional anesthesia.
Detailed description
This is a randomized controlled clinical study on patients who were followed during their forearm orthopedic surgery. The research has been submitted and approved by the Institutional review Board (IRB) at the American Hospital of Paris. Before their inclusion in the study, after to give their consentment, patients were verbally given details about the methods and techniques of the music session.
Patients scheduled to undergo forearm orthopedic surgery (SR) under regional anesthesia are recruited in this study. They are assigned to one of 2 groups in a randomized manner. Excluding criteria are age less 18 years or up 80 years, patients who do not like music for cultural reason, having serious psychiatric disorder, or with not paired deafness or paired one with devices that were incompatible with wearing a headset. After randomization, patients are placed in the control group, using a music support from playlist, or assigned to the MUSICARE group.
In both group, after per os hydroxyzine premedication, each patient received a regional anesthesia using mepivacaine 2%, at least 20 minutes before skin incision under tourniquet. The regional anesthesia is performed using either an axillary plexus block or mild-arm trunk nerve block with electrical nerve stimulation and ultrasound nerve localization. The music support is started before to do the regional anesthesia and continued during all the orthopedic procedure. According to the anxiety level and patient request, an intravenous titration of midazolam was infused 1 mg per 1 mg to get a sedative score less or equal to 1. If this target is not met after 3 mg of midazolam, the anesthetist could infuse a low dose of propofol (20 mg).
During all the procedure, the anesthetist performing the regional anesthesia and the intravenous hypnotic administration, is blinded about the patient group and musicThe Music-Care app is a receptive music intervention, allowing the patient to freely adjust the length of and choose the preferred style between different sequences of instrumental music. All musical pieces were recorded in high-quality recording studios with professional musicians.
Music-Care utilizes the "U" technique, designed to gradually relax the listener. In the current study, music sequences during patients' sessions were based on the mount "U", and instrumental musical works were selected for a varying numbers styles (classical, jazz, world music, etc.) and adapted to the patient's style via patient request. The "U" technique is implemented using a musical sequence of 20 minutes that was divided into 5 different musical pieces at 3 to 4 minutes each. Initially, the objective is to represent the patient's state of tension by stimulating musical rhythm of 80-95 beats per minute (bpm). From there, the remaining 4 sub-pieces are presented in a blended fashion in an attempt for the patient to gradually fall into a relaxed state via a gradual reduction in musical tempo (40-80 bpm), orchestral size, frequencies, and volume (descending arm of the "U"). The music session then reaches a phase of maximum relaxation (downward phase of the "U") before a phase that gradually returns to baseline dynamics (ascending arm of the "U").
In the control group, a music program from an established playlist with various instrumental music is chosen by the patient and delivered by the same tablet.
program. The primary study end points were the consumptions in sedatives (midazolam and propofol), from 10 minutes prior to the procedure until its end. Secondary study end points were pain and anxiety scores as measured the Numeric Rating Scale (NRS) and the Amsterdam Preoperative Anxiety and Information Scale (APAIS), collected before and right after the end of the procedure in the recovery room. We also evaluated the physiological parameters, such as sedation score ( 0: awake; 1: unconsciousness but reactive to verbal stimulation; 2: unconsciousness but reactive to nociceptive stimulation; 3: areactive to stimulation) , heart rate, arterial blood pressure, oxygen saturation at different time points between T0 (10 minutes prior to the beginning of the procedure) and T45 (45 minutes after it). Satisfaction was also collected using a scale from 0 to 5, with a higher score for a high satisfaction, right after the end of the procedure in the recovery room.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- In this study, the investigators compare a specific program of music therapy to an usual music support by playlist. The specific program MUSIC-CARE is administered through a hardware and software, consisting of a modern tablet. The Music-Care app is a receptive music intervention, allowing the patient to freely adjust the length of and choose the preferred style between different sequences of instrumental music. All musical pieces were recorded in high-quality recording studios with professional musicians. Music-Care utilizes the "U" technique designed to gradually relax the listener. Initially, the objective is to represent the patient's state of tension by stimulating musical rhythm of 80-95 beats per minute (bpm). Then, it gradually falls into a relaxed state via a gradual reduction in musical tempo (40-80 bpm), orchestral size, frequencies, and volume (descending arm of the "U").
| Arm | Type | Receives |
|---|---|---|
| MUSIC-CARE Group | Active comparator | Other: Music-CareIn the Music-Care group, a program of music therapy was administered through a hardware and software provided to the investigative team by the Music-Care Company. The standardized techniques include three sequences in which the relaxing, maintenance and simulating times differ. Music-Care utilizes the "U" technique designed to gradually relax the listener. In the current study, music sequences during patients' sessions were based on the mount "U", and instrumental musical works were selected for a varying numbers styles (classical, jazz, world music, etc.) and adapted to the patient's style via patient request. |
| CONTROL group | Sham comparator | Other: control groupIn the control group, a music program from an established playlist with various instrumental music is chosen by the patient and delivered by the same tablet. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- scheduled forearm orthopedic surgery
- locoregional anesthesia
Key exclusion criteria (8 listed)
- age below 18 yrs or up to 80 yrs
- emergency
- surgery duration up to 90 minutes
- patient refusing locoregional anesthesia
- local contreindication to locoregional anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music-Caremusic relaxation by a specific hardware and software program application (MUSIC-CARE) | Other | MUSIC-CARE Group |
| control groupmusic relaxation using a music playlist supply (control group) | Other | CONTROL group |
Primary outcome
sedative requirement
Time frame: during the intraoperative period
midazolam and/or propofol peroperative consumption in milligramme
4 secondary outcomes
anxiety score change
Time frame: during the intraoperative period
pain score change
Time frame: during the intraoperative period
sedation score change
Time frame: during the intraoperative period
satisfaction score
Time frame: in postoperative period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
- Background: PubMed 26277246Hole J, Hirsch M, Ball E, Meads C. Music as an aid for postoperative recovery in adults: a systematic review and meta-analysis. Lancet. 2015 Oct 24;386(10004):1659-71. doi: 10.1016/S0140-6736(15)60169-6. Epub 2015 Aug 12.
- Background: PubMed 22001666Guetin S, Ginies P, Siou DK, Picot MC, Pommie C, Guldner E, Gosp AM, Ostyn K, Coudeyre E, Touchon J. The effects of music intervention in the management of chronic pain: a single-blind, randomized, controlled trial. Clin J Pain. 2012 May;28(4):329-37. doi: 10.1097/AJP.0b013e31822be973.
- Background: PubMed 31320504Graff V, Cai L, Badiola I, Elkassabany NM. Music versus midazolam during preoperative nerve block placements: a prospective randomized controlled study. Reg Anesth Pain Med. 2019 Jul 18:rapm-2018-100251. doi: 10.1136/rapm-2018-100251. Online ahead of print.
- Background: PubMed 31326711Fu VX, Oomens P, Sneiders D, van den Berg SAA, Feelders RA, Wijnhoven BPL, Jeekel J. The Effect of Perioperative Music on the Stress Response to Surgery: A Meta-analysis. J Surg Res. 2019 Dec;244:444-455. doi: 10.1016/j.jss.2019.06.052. Epub 2019 Jul 18.
- Background: PubMed 24280479Zengin S, Kabul S, Al B, Sarcan E, Dogan M, Yildirim C. Effects of music therapy on pain and anxiety in patients undergoing port catheter placement procedure. Complement Ther Med. 2013 Dec;21(6):689-96. doi: 10.1016/j.ctim.2013.08.017. Epub 2013 Sep 1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilles BOCCARA, MD, PhD principal investigator
American Hospital of Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music-Care in people with Regional Anesthesia and Music, run by American Hospital of Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gilles BOCCARA, MD, PhD (+33 1 46 41 26 91, gilles.boccara@ahparis.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sedative requirement (time frame: during the intraoperative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05015985, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2023.